Guide catheter control flexible track

ABSTRACT

A robotic catheter system includes a base and a robotic mechanism having a longitudinal axis and being movable relative to the base along the longitudinal axis. A flexible track is releasably secured to the base and includes an outer surface having a longitudinal opening slit extending therethrough to an inner channel. A rigid guide has a non-linear portion fixed relative to the robotic mechanism. A portion of the flexible track moves along the non-linear portion of the rigid guide away from the longitudinal axis when the robotic mechanism moves along the longitudinal axis.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/891,389, filed Oct. 15, 2013, entitled “GUIDE CATHETER CONTROLBENDABLE SUPPORT”, and U.S. Provisional Application No. 61/952,872,filed Mar. 14, 2014, entitled “GUIDE CATHETER CONTROL BENDABLE SUPPORT”,both of which are incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

The present application relates generally to the field of cathetersystems for performing diagnostic and/or percutaneous coronaryintervention procedures. The present application relates specifically toa guide catheter control in a robotic catheter system.

Vascular disease, and in particular cardiovascular disease, may betreated in a variety of ways. Surgery, such as cardiac bypass surgery,is one method for treating cardiovascular disease. However, undercertain circumstances, vascular disease may be treated with a catheterbased intervention procedure, such as angioplasty. Catheter basedintervention procedures are generally considered less invasive thansurgery.

During one type of intervention procedure, a guide catheter is insertedinto a patient's femoral artery through an introducer and positionedproximate the coronary ostium of a patient's heart. A guide wire isinserted into the guide catheter typically through a hemostasis valveand maneuvered through the patient's arterial system until the guidewire reaches the site of the lesion. A working catheter is then movedalong the guide wire until the working catheter such as a balloon andstent are positioned proximate the lesion to open a blockage to allowfor an increased flow of blood proximate the lesion. In addition tocardiovascular disease, other diseases may be treated withcatheterization procedures.

SUMMARY

In one embodiment a robotic catheter system includes a base and arobotic mechanism having a longitudinal axis and being movable relativeto the base along the longitudinal axis. A flexible track is releasablysecured to the base and includes an outer surface having a longitudinalopening slit extending therethrough to an inner channel. A rigid guidehas a non-linear portion fixed relative to the robotic mechanism. Aportion of the flexible track moves along the non-linear portion of therigid guide away from the longitudinal axis when the robotic mechanismmoves along the longitudinal axis.

In one embodiment a method of supporting an elongated medical deviceincludes translating a robotic mechanism along a longitudinal axisrelative to a base. The robotic mechanism includes a rigid guide havinga distal portion along the longitudinal axis and an offset portionoffset from the longitudinal axis. The method further includes providinga flexible track having a slit extending into an interior region;placing the flexible track within the rigid guide; operatively fixing aportion of the flexible track to the base; and moving a portion of theflexible track between the offset portion and the distal portion as therobotic mechanism extends and retracts along the longitudinal axis.

In one embodiment an apparatus includes a base and a robotic mechanismmovable along a longitudinal axis relative to a base by a linear drive.The robotic mechanism includes a rigid guide having a distal portionalong the longitudinal axis and an offset portion offset from thelongitudinal axis. A flexible track has an interior region and includesa portion being operatively fixed to the base. The flexible trackincludes a portion within the rigid guide. An elongated medical deviceextends from the robotic mechanism and extends along the longitudinalaxis. A portion of the flexible track moves between the offset portionand the distal portion of the rigid guide as the robotic mechanismextends and retracts along the longitudinal axis and extends about theelongated medical device proximate the juncture between the offsetportion and the distal portion of the rigid guide as the roboticmechanism extends along the longitudinal axis.

In a further aspect of one embodiment the proximal end and the distalend of the flexible track remain in a fixed location as the roboticmechanism is moved along the longitudinal axis.

In one embodiment a support system for the portion of a guide catheterextending between a patient into whom the guide catheter has beenintroduced and a robotic mechanism for incremental movement of the guidecatheter includes a flexible track having an internal channel. Theflexible track includes a slit extending longitudinally along the track,the slit removeably receives a portion of guide catheter therethrough. Arigid guide fixed relative to the robotic mechanism provides an accuratepath for the flexible track which path proceeds from the portion of therobotic mechanism to the longitudinal axis of the guide catheter thatextends from the robotic mechanism connected to a position offset fromthe longitudinal axis.

In one embodiment a support system for a guide catheter includes aflexible track having a longitudinal slit that receives a guide catheterinto a cavity of the track while the guide catheter is in a straightorientation. A rigid guide guides the flexible track toward and awayfrom a longitudinal axis of the guide catheter. The flexible track beingcoaxial with the guide catheter between an entry point of the guidecatheter into the cavity of the flexible track and not being coaxialwith the guide catheter for at least a portion of the flexible trackbetween the entry point and a proximal end of the flexible support.

In one embodiment a system for manipulating a guide catheter that hasbeen inserted into a human patient for the performance of a percutaneousprocedure is also provided. It includes a robotic mechanism foradvancing a guide wire and/or a working catheter into the proximal endof the guide catheter, a guide catheter affixed to the distal end of therobotic mechanism and a support system for supporting the portion of theguide catheter extending between the patient and the robotic mechanism.The support system includes a flexible track which carries a channelinto which a portion of guide catheter may be releasably inserted, arigid guide affixed to the robotic mechanism and provides a path for theflexible track toward and away from a longitudinal axis of the guidecatheter as the distal end of the guide catheter is moved toward andaway from a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

This application will become more fully understood from the followingdetailed description, taken in conjunction with the accompanyingfigures, wherein like reference numerals refer to like elements inwhich:

FIG. 1 is an isometric view of a robotic catheter system.

FIG. 2 is top isometric view of a front portion of the robotic cathetersystem of FIG. 1 with an exploded view of a guide catheter andY-connector.

FIG. 3 is a side front view of the front portion of the robotic cathetersystem of FIG. 2 with the guide catheter positioned within a Y-connectorsupport in a raised position.

FIG. 4 is an isometric view of the portion of the system of FIG. 2 withthe Y-connector and support in a lowered position with the Y-connectorsupport cover in the raised position.

FIG. 5 is a top plan view of the front portion of the robotic cathetersystem of FIG. 2 with the guide catheter in the engaged position.

FIG. 6A is an isometric view of the robotic catheter system with thesheath clip in an install position.

FIG. 6B is an isometric view of the robotic catheter system with thesheath clip in an engaged position.

FIG. 7 is an exploded view of the arcuate portion of the rigid guide andfront of the robotic catheter system.

FIG. 8 is a close up of the sheath clip, flexible track and rigidsupport of FIG. 7.

FIG. 9 is an exploded view of the sheath clip and distal end of therigid guide.

FIG. 10 is an isometric view of the front portion of the roboticcatheter system with the flexible track in an extended position.

FIG. 11 is cross-sectional view of the front portion of the roboticcatheter system taken generally along line 11-11 of FIG. 5 showing anextension member protruding into a slit of the flexible track.

FIG. 12 is a cross-sectional view of the front portion of the roboticcatheter system taken generally along lines 12-12 of FIG. 6A with thesheath clip in an in-load position.

FIG. 13 is a cross-sectional view of the front portion of the roboticcatheter system taken generally along lines 13-13 of FIG. 6B with thesheath clip in the operational position.

FIG. 14 is a top plan view of the robotic catheter system with theflexible track in the fully retracted position.

FIG. 15 is a top plan view of the robotic catheter system with theflexible track in an extended position.

FIG. 16 is a top plan view of the robotic catheter system with therobotic drive in a first position.

FIG. 17 is a top plan view of the robotic catheter system with therobotic drive in a second extended position.

FIG. 18 is a rear isometric view of the robotic catheter system with alinear drive.

FIG. 19 is an exploded rear isometric view of the robotic cathetersystem with the cassette in a pre-assembly position relative to therobotic drive base.

FIG. 20 is a rear isometric view of the robotic catheter system with thecassette secured to the robotic drive base with the locking track clampin the disengaged position.

FIG. 21 is a close up view of the locking track clamp taken generallyalong lines 21-21 of FIG. 20.

FIG. 22 is a close-up isometric view of the locking track clamp in anengaged position.

FIG. 23 is a cross-sectional view of the locking track clamp in anengaged position and unlocked.

FIG. 24 is an exploded view of a portion of the locking track clamp.

FIG. 25A is a cross-sectional view of the locking track clamp in anunlocked position.

FIG. 26A is a cross-sectional view of the locking track clamp in anunlocked position.

FIG. 25B is a cross-sectional view of the locking track clamp in alocked position.

FIG. 26B is a cross-sectional view of the locking track clamp in thelocked position.

FIG. 27 is a schematic view of the robotic catheter system with a remotecontrol station.

FIG. 28 is illustration of robotic catheter system with the guidecatheter engaged with a patient.

FIG. 29 is a view of a hemostasis valve control mechanism.

FIG. 30 is a cross-sectional view of the hemostasis valve illustratingthe opening and closing the back portion of the hemostasis valve.

FIG. 31 is an isometric view of a sheath clip.

FIG. 32 is an isometric view of the sheath clip of FIG. 31 with anintroducer.

FIG. 33 is an isometric view of the sheath clip of FIG. 31 with anintroducer connected to the sheath clip.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIG. 1 a robotic catheter system 210 includes a roboticmechanism 212 robotically moving an elongated medical device. Therobotic mechanism 212 is movable relative to a base 214. A flexibletrack 216 is movable along a rigid guide track 218 having a non-linearportion. Referring to FIG. 16 flexible track 216 includes a proximal end253 and a distal end 254.

As described in more detail herein, flexible track 216 supports anelongated medical device such as a guide catheter so that the guidecatheter can be advanced into the patient without buckling.

As used herein the direction distal is the direction toward the patientand the direction proximal is the direction away from the patient. Theterm up and upper refers to the general direction away from thedirection of gravity and the term bottom, lower and down refers to thegeneral direction of gravity. The term front refers to the side of therobotic mechanism that faces a user and away from the articulating arm.The term rear refers to the side of the robotic mechanism that isclosest to the articulating arm. The term inwardly refers to the innerportion of a feature. The term outwardly refers to the outward portionof a feature.

Robotic mechanism 212 includes a robotic drive base 220 movable relativeto base 214 and a cassette 222 that is operatively secured to roboticdrive base 220. In one embodiment cassette 222 includes structure thatdefines support rigid guide 218. In one embodiment base 214 alone or incombination with cassette 222 defines rigid guide 218.

In one embodiment base 214 is secured to an articulating arm 224 thatallows a user to position robotic mechanism 212 proximate a patient. Inone embodiment base 214 is the distal portion of the articulating arm224. Articulating arm 224 is secured to a patient bed by a rail clamp ora bed clamp 226. In this manner base 214 is secured to a patient bed. Bymanipulation of articulated arm 224 the base 214 is placed in a fixedlocation relative to a patient that lies upon the patient bed. The armsof articulated arm 224 can be fixed once the desired location of roboticmechanism 212 is set relative to the patient.

Referring to FIG. 2 an elongated medical device such as a guide catheter228 is operatively secured to robotic mechanism 212 through cassette222. Guide catheter 228 includes a proximal end 230, an opposing distalend 232, and an intermediate portion 234 extending between the proximalend 230 and distal end 232. In one embodiment proximal end 230 of guidecatheter 228 is operatively secured to a Y-connector 233 and Y-connectorengagement mechanism 236. In one embodiment Y-connector 233 is ahemostasis valve that is secured to cassette 222 by a Y-connectorengagement mechanism 236 including a Y-connector base 238 that is partof cassette 222 and an enclosure member 244 including a lid 243 and asupport member 245. Y-connector base 238 includes a guide catheter drivemechanism 240 located in the cassette 222 which in turn is operativelyconnected to robotic base 220. Guide catheter drive mechanism 240includes a drive mechanism that operatively engages and rotates guidecatheter 228 along its longitudinal axis correction about itslongitudinal axis based on commands provided by a remote control center.

Referring to FIG. 3, Y connector enclosure 244 pivots to a raisedinstall position to provide easy installation of guide catheter 228 andY-connector 233. Referring to FIG. 4, the Y-connector enclosure 244pivots along vector 242 from the raised position to an in-useoperational lower position. In one embodiment guide catheter drivemechanism 240 interacts with a gear 241 on a rotating luer lockconnector secured to proximal end 230 of guide catheter 228 torobotically rotate guide catheter 228 about its longitudinal axis. Theoperation of a Y-connector holder and drive mechanism 236 to roboticallyrotate guide catheter 228 about its longitudinal axis is described inpublished US Patent Application No. US 2014/0171863 A1 entitledHemostasis Valve for Guide Catheter Control which is incorporated hereinby reference in its entirety. The robotic control of the Y-connectorhemostasis valve 233 will be discussed in further detail below.

Referring to FIG. 4 and FIG. 6, Y connector holder 238 includes a cover244 which pivots from an open position to a closed position. Y connectorholder 238 is releasably engaged to a portion of cassette 222 by arelease button 246. Movement of lever 246 allows Y connector holder 238to be pivoted from the operational lower position to the raised positionto load guide catheter 228 and Y-connector 233.

Referring to FIG. 5 the relationship between guide catheter 228, rigidguide 218, and flexible track 216 will be described. Guide catheter 228maintains a linear position along its longitudinal axis 248 withincassette 222 and for at least a certain distance distal cassette 222. Inone embodiment longitudinal axis 248 corresponds to the longitudinalaxis of cassette 222.

During a medical procedure such as a percutaneous coronary intervention(PCI) guide catheter 228 is used to guide other elongated medicaldevices such as a guide wire and balloon stent catheter into a patientto conduct an exploratory diagnosis or to treat a stenosis within apatient's vasculature system. In one such procedure the distal end 232of the guide catheter 228 is seated within the ostium of a patient'sheart. Robotic mechanism 212 drives a guide wire and/or a workingcatheter such as a balloon stent catheter in and out of a patient. Theguide wire and working catheter are driven in within the guide catheter228 between the distal end of the robotic mechanism 212 and the patient.In one embodiment longitudinal axis 248 is the axis about which cassette222 causes rotation of a guide wire and the axis along which cassette222 drives the guide wire along its longitudinal axis and drives aworking catheter such as a balloon stent catheter along its longitudinalaxis. In one embodiment the robotic drive system is of the typedescribed in U.S. Pat. No. 7,887,549 entitled Catheter System andincorporated herein by reference in its entirety.

Referring to FIGS. 5, 7 and 9 a collar 250 is formed at the distal endof rigid guide 218. Collar 250 includes a vertically extending opening278 through which guide catheter 228 is loaded into flexible track 216.

The terminal end 254 of flexible track 216 is secured to a sheath clip256 which is releasably connected to cassette 222. Flexible track 246includes a collar 250 secured to a terminal distal end 252. Referring toFIG. 9 in one embodiment a sheath clip 256 includes a proximal end 258including an attachment portion 260. The distal end 254 of flexibletrack 216 is secured to attachment portion 260. Sheath clip 256 includesa grasping portion 262 that allows a user to manipulate sheath clip 256and flexible track 216. Intermediate the grip portion 262 and theflexible track attachment portion 260 is a collar engagement portion264. Collar engagement portion 264 and includes a guiding locatingmember 266 configured to position sheath clip 256 within collar 250.

Referring to FIG. 7 rigid guide 218 includes a top member 268 and abottom channel member 270. Top member 268 and bottom channel member 270when secured together with a plurality of fasteners or other fasteningmechanism forms a interior channel 272 through which flexible track 216moves relative to rigid guide 218.

Referring to FIG. 8 flexible track 216 includes an opening 274 locatedadjacent to the terminal end 254 of flexible track 216 a predetermineddistance toward proximal end of flexible track 216. When distal end 254of flexible track 216 is positioned adjacent collar 250 opening 274extends from collar 250 toward Y-connector holder a distance sufficientsuch that opening 274 extends from collar 250 to the area in which rigidguide 218 begins an arcuate path away from longitudinal axis 248. In oneembodiment arcuate path forms an s-curve having at least one point ofinflection along the arcuate path. As discussed below opening 274provides a path for guide catheter 228 to be placed into the hollowcavity of flexible track directly from a position above longitudinalaxis. In this manner guide catheter 228 may be placed within flexibletrack 216 proximate opening 274 while guide catheter 228 is linear.Stated another way in one embodiment guide catheter 228 is in a straightline when the guide catheter 228 is inserted through opening 274. In oneembodiment opening 274 extends 90 degrees about the opening of theterminal end 254 of flexible track 216. Opening 274 tapers to a slit 286that extends substantially the entire length of flexible track 216. Inone embodiment slit 286 extends from opening 274 a distance sufficientto allow guide catheter 228 to enter and exit an interior portion offlexible track 216 throughout the entire intended operation of roboticcatheter system. Opening 274 is defined by a pair of substantiallyparallel cut lines 288, 290 in the outer surface of flexible track 216.Opening 274 is further defined by a tapered region 294 with an arcuateline 296 extending from cut line 288 toward slit 286. In one embodimentflexible track 216 has sufficient rigidity to maintain slit 286 in theopen position, that is the two portions of the outer surface of flexibletrack 216 that define slit 286 remain separated during movement of theflexible track 216 as described herein and do not collapse onto oneanother such that no opening is present. In one embodiment slit 286collapses during certain portions of flexible track 216 as it movesthrough certain sections of rigid guide 218. In one embodiment slit 286collapses that is the two edges that define the slit are in contact withone another except in the area in which guide catheter 228 enters andexits flexible track 218. The edges defining the slit are forced apartby extension member 298 in the region where the longitudinal axis 248 iscoincident with the portion of rigid guide that begins the non-lineararcuate portion.

Referring to FIG. 1 the distal end of flexible track 216 is fed into thechannel of rigid guide 218 through its proximal opening 276. Rigid guide218 includes a linear portion beginning at proximal opening 276 and anon-linear portion defined by cover 268 and base 270. In one embodimentthe non-linear portion is an arcuate portion having at least one pointof inflection. Flexible track 216 is initially positioned within rigidguide 218 by feeding distal end 254 of flexible track 218 into proximalopening 276 of rigid guide 218 until the distal end 254 of flexibletrack 216 extends beyond collar 250 of rigid guide 218. The distal end254 of flexible track 216 is operatively connected to member 258 ofsheath clip 256. Sheath clip 258 is positioned within collar 250 suchthat member 266 is positioned within a corresponding mating groove incollar 250. Sheath clip 256 is positioned in a first load position withchannel opening 276 of sheath clip 258 aligned with opening 278 ofcollar 250.

Flexible track 216 is rotated by a technician or operator within rigidguide 218 such that opening 274 faces in an upwardly direction. Statedanother way opening 274 of flexible track 216 is secured to sheath clip256 in a manner such that when she clip 256 is engaged with collar 250opening 276 of sheath clip 256 is aligned with opening 278 of collar 250which is also aligned with opening 274 of flexible track 216.

Referring to FIG. 10 flexible track 216 is secured to sheath clip 256with a portion of flexible track 216 extending beyond collar 250 in thedistal position. The extension of the distal end 254 of flexible track216 allows for easy insertion of flexible track 216 to sheath clip 256.Since flexible track 216 is formed of a flexible material having amodulus of elasticity that is less than the modulus of elasticity of therigid guide material, flexible track 216 moves along the curvednon-lineal portion of channel defined by rigid guide 218. Note that themodulus of elasticity of flexible track 216 is below a value in whichflexible track 216 will fracture or break by movement along thenon-linear portion of rigid guide 218. In one embodiment flexible track216 is formed of a polytetrafluoroethylene PTFE material. Sheath clip256 along with the terminal end 254 of flexible track 216 is movedadjacent to collar 250. Sheath clip 256 along with flexible track 216 isrotated to such that the opening 276 of sheath clip 256 is alignmentwith opening 278 of collar 250 defining the guide catheter installationposition. As discussed below in one embodiment a sheath clip 420 isconfigured to be received within cassette 222 in the proper installorientation.

Referring to FIG. 5 guide catheter 228 is positioned within opening 274of flexible track 216 through opening 278 of collar 250 and throughopening 276 of sheath clip 256. Referring to FIG. 5 and FIG. 9 thedistal end 280 of sheath clip 256 includes a collar 282 having anopening 284. Guide catheter 228 in the installation position extendsinto flexible track 216 through opening 274, through opening 278 ofcollar 250 and through openings 276, 284 of sheath clip 256. In thisinstallation position guide catheter 228 maintains a straight and linearorientation along its longitudinal axis 248 from Y-connector holder 236through the distal end of sheath clip 256.

Referring to FIG. 11, rigid guide 218 includes an extension member 298that extends into the channel defined by the outer walls of rigid guide218. Extension member 298 is received into the inner channel of flexibletrack 218 through slit 286. Extension member 298 is positioned proximatethe distal end 300 of the arcuate portion of rigid guide 218. Extensionmember 298 has a thickness that is equal to or greater than the openingdefined by slit 286 to ensure that the edges of flexible track 216 thatdefine the slit remains separated so that guide catheter 228 can extendinto the channel portion of flexible track 216 through the slit. In oneembodiment the thickness of extension member 298 is greater than theopening defined by the slit and the diameter of the guide catheter 228.In this manner the opening defined by the slit 286 is increased at andclosely adjacent to the extension member allowing for insertion andremoval a portion of guide catheter 228. In one embodiment the openingdefined by the slit is less than the diameter of the guide catheter 228which assists in maintaining the distal portion of the guide catheterwithin the channel of the flexible track 216 during operation of therobotic catheter system.

Referring to FIG. 6A, and FIG. 12, sheath clip 256 is placed in aninstallation position with opening 276 in the upward direction. Statedanother way opening 276 is formed by a channel in sheath clip 256defining an opening that is accessed from the upward direction. Thisorientation allows guide catheter 228 to be positioned within thechannel of sheath clip 256 and opening 274 of flexible track 216 in thesame orientation that guide catheter is secured to cassette 222. In thisorientation guide catheter 228 can be placed into the channel offlexible track 216 through openings 276 and 284 of sheath clip 256 andthrough opening 274 of flexible track 216.

Referring to FIG. 6B and FIG. 13, in one embodiment sheath clip 256 isrotated about longitudinal axis 248 until opening 276 extends 90 degreesfrom the vertical orientation sown in FIG. 12. In this manner guidecatheter 228 is assisted in remaining within the channel of flexibletrack 216. As sheath clip 256 is rotated 90 degrees, extension member298 acts to widen the opening defined by slit 286 immediately adjacentthe longitudinal axis 248. In this manner guide catheter 228 can enterand exit flexible track 216 without interference from the edges of theflexible track that defines slit 286. In one embodiment described belowa sheath clip 420 does not need to be rotated but simply pulled distallyaway from cassette 222.

In one embodiment sheath clip 256 is rotated in a first direction 90degrees illustrated in FIG. 6B, while in another embodiment sheath clip256 is rotated 90 degrees in a direction opposite to the direction. Itis also contemplated that sheath clip 256 may be rotated less than orgreater than 90 degrees. In one embodiment described below sheath clip420 does not need to be rotated.

Referring to FIG. 14 and FIG. 15 in one embodiment once sheath clip 256has been rotated to the operation position shown in FIG. 13, the sheathclip is pulled by a user away from cassette 222 in a direction alonglongitudinal axis 248 until the distal end 280 sheath clip 256 isproximate the patient. In one embodiment an introducer is secured todistal end 280 of sheath clip 256. The introducer is a device that issecured to a patient to positively position the introducer to thepatient to allow insertion and removal of elongated medical devices suchas the guide catheter, guide wire and or working catheter into thepatient with minimal tissue damage to the patient. Once the operator haspulled the sheath clip and accompanying flexible track toward thepatient such that the introducer is proximate the patient, the flexibletrack is locked in position by a locking clamp 310.

Locking clamp 310 secures flexible track 216 to base 214 such that aportion of flexible track 216 is in a fixed position relative to thepatient bed and the patient to the extent the patient lies still on thepatient bed. Referring to FIG. 18, a linear drive mechanism 312 includesa linear slide that is robotically controlled by a user through a remotecontrol station. Catheter drive mechanism drive 312 drives roboticmechanism 212 along longitudinal axis 248. Since rigid guide 218 isfixed relative to robotic mechanism 212, flexible track 216 movesrelative to the rigid guide 218 as the robotic mechanism 212 moves alongthe longitudinal axis 248.

Referring to FIGS. 14, 15, 16 and 17 the operation and movement offlexible track 216 relative to rigid guide 218 will be described.Referring to FIG. 14 flexible track 216 is shown in the installationfirst position in which guide catheter 228 is positioned within sheathclip 256 and flexible track opening 274 as described above. Referring toFIG. 15, once sheath clip 256 has been released from the cassette 222 asdescribed above the sheath clip 256 and distal end of the flexible trackare pulled by a user away from cassette 222 such that the distal end ofthe sheath clip 256 is proximate the entry point of the patient in whicha percutaneous intervention will occur. As described below in furtherdetail locking clamp 310 operatively clamps a portion of flexible track216 that flexible track 216 fixed relative to base 214.

Referring to FIGS. 14 and 15 the portion of flexible track 216 that ispositioned within arcuate portion of rigid guide 218 is pulled out ofthe distal end of rigid guide 218 in a direction generally alonglongitudinal axis 248. Similarly a portion 322 of flexible track 216that was external to and not located within the arcuate portion of rigidguide 218 is pulled into the arcuate portion of rigid guide 218 anddepending on how far the terminal end of the flexible track is pulledtoward the patient portion 322 of flexible track 216 will enter thearcuate portion of rigid guide 218 and may extend therefrom. Statedanother way flexible track 216 includes three general regions thatchange with the operation of the guide catheter system. First a proximalregion that includes the flexible track portion from the proximal end253 to the opening 324 of the arcuate portion of rigid guide 218.Flexible track 216 includes a second portion located between theproximal end 324 of the arcuate portion of rigid guide 218 and thedistal end 325 of the arcuate portion of rigid guide proximate collar250. Flexible track includes a third region that extends from collar 250of rigid guide 218 in a direction defined by a vector generally alonglongitudinal axis 248, where the vector has a beginning at Y-connectorand extends in a direction toward collar 250.

The first region and second region of flexible track 216 as describedabove is offset from and not in line with longitudinal axis 248. Thethird portion of flexible track 216 is generally coaxial withlongitudinal axis 248 as flexible track 216 exits collar 250 of rigidguide 218.

During one type of intervention procedure, guide catheter 228 isinserted into a patient's femoral artery through an introducer andpositioned proximate the coronary ostium of a patient's heart. Anoperator may wish to relocate the distal end of the guide catheterrobotically. Referring to FIG. 16 and FIG. 17 the control of the distalend of guide catheter 228 will be described. Referring to FIG. 16 guidecatheter 228 has a distal portion which extends beyond the distal end ofsheath clip 256 in order to extend beyond the terminal end of guidecatheter 228 in a direction away from the terminal end of sheath clip.As noted above the distal end of guide catheter 228 may be placedproximate the ostium of a patient. The robotic control of the distal endof guide catheter 228 is accomplished by movement of robotic drivemechanism 212 relative to base 214 by linear drive 312. Guide catheteris located within the channel of the flexible track from cassette 222until the sheath clip 256. Since flexible track 216 is secured relativeto base 214 the second portion of flexible track 216 as described abovewill move from within the arcuate portion of rigid guide 218 to aposition offset from longitudinal axis 248. Similarly a third portion offlexible track 216 that extended distally beyond collar 250 will beretracted and moved into the arcuate portion of rigid guide 218 and indoing so is moved away from and offset from longitudinal axis 248.

If during a PCI procedure guide catheter begins to slip out of theostium it is possible to extend the distal end of guide catheter 228back into the patient's ostium by robotically moving the robotic drive212 toward the patient. In doing so the distal end of guide catheter 228is moved toward the patient reinserting or seating the distal end of theguide catheter into the patient's ostium as one example. As the roboticdrive mechanism 212 is moved along longitudinal axis 248 flexible track216 is moved relative to rigid guide 218. In actual operation a portionof flexible track 216 is fixed in space relative to base 214 at lockingclamp 310. However, the portion of flexible track 216 that is locatedwithin the arcuate section of rigid guide 216 is moved toward and awayfrom longitudinal axis 248 depending on the direction that the roboticdrive mechanism 212 is moving. Guide catheter 228 moves into or out ofthe section of the flexible track 216 that is moving in and out of thearcuate portion of rigid guide 218. In this manner the portion of theguide catheter 228 between cassette 222 and the sheath clip is alwayslocated within the channel of flexible track 216. In this manner guidecatheter 228 may be manipulated within flexible track 216 withoutbuckling or causing other non-desirable movement during a percutaneousintervention procedure.

Referring to FIG. 16 and FIG. 17 the movement of flexible track 216 withrespect to rigid guide 218 will be described as it relates to singlesection A on flexible track 216. In one example section A on flexibletrack 216 is located distal collar 250 of rigid guide 218. When anoperator determines to insert guide catheter 228 further into or towarda patient in a direction away from collar 250 an input device ismanipulated by the user at a remote control station that drives roboticdrive 212 distally along longitudinal axis 248 by activating lineardrive 312. The proximal end of guide catheter 228 is longitudinallyfixed in cassette 222 by clamp 310 so that as the robotic drive 312including cassette 222 is moved relative to base 214 by linear drive312, in a direction toward the patient guide catheter 228 moves distallyalong longitudinal axis 248. As a result the distal end of guidecatheter 228 moves toward and/or into the patient.

As the robotic drive mechanism is moved along longitudinal axis 248section A of flexible track 216 moves into rigid guide 218 throughcollar 250 and is moved along the arcuate portion of rigid guide 218until section A of the flexible track 216 is adjacent the proximateopening of rigid guide 218. In this manner distal end of flexible trackremains in a constant position but section A of flexible track 216 ismoved out of or offset to the longitudinal axis 248. As section A movesfrom a point proximate the collar 250 into the arcuate channel definedby the rigid guide 218 the guide catheter 228 enters the channel orhollow lumen of the flexible track 216 through the slit adjacent in theengagement zone proximal to collar 250. In this manner flexible track216 provides continual support and guidance for the guide catheter 228between the collar 250 and patient as the distal end of guide catheter228 is moved toward and away from the patient.

Similarly, if the operator desires to retract the distal end of theguide catheter 228 from within the patient, the user provides a commandto the linear drive through the remote control station to move roboticdrive mechanism 212 in a direction away from the patient. In this waysection A of the flexible track 216 would enter the proximal end of thearcuate portion of the rigid guide and be guided within the channel ofthe rigid guide 218 until section A exits the distal end of the rigidguide 218. The guide catheter 228 would enter the slit at section A orstated another way a portion of the guide catheter 228 would enter theflexible track 216 via the portion of the slit that is located withinthe concentric circle taken at section A of the flexible track. Notethat although sections of flexible track are positioned in differentregions of the rigid guide as the robotic mechanism in moved toward andaway from the patient the proximal end and the distal end of theflexible track remain in a fixed location as the robotic mechanism ismoved along the longitudinal axis.

Referring to FIGS. 19-26 locking clamp 310 includes a base portion 320operatively connected to base 214 and a clamp portion 322 that iscoupled to base portion 320 via an engagement mechanism 324. Engagementmechanism 324 includes a pair of clasps 370, 371 on base portion 320that engage a portion 357 via two indentations or grooves 360 and 362 onclamp portion 322. Clamp portion 322 includes a body 326 having a rigidguide connector 328 that is pivotally received in an opening in therigid guide. Connector 328 includes a cylindrical member 356 that isreceived within the opening in rigid guide 218. Referring to FIG. 21Clamp portion 322 is in a raised position that can be used to ship thecassette separately from robotic drive base 220 without clamp portion322 extending outwardly or rearwardly from cassette 222. Clamp portion322 pivots about the longitudinal axis of rigid guide 218 proximate theopening in rigid guide 218 to an outwardly orientation to be coupled tobase portion 320.

Referring to FIG. 24, cylindrical member 356 defines a channel extendingtherethrough through which flexible track 216 extends. Extendinginwardly into the channel from the cylindrical member 356 is a flatsupport 332. An inner cylindrical guide member 330 extends from flatsupport 332 such that cylindrical guide member is coaxial with thecylindrical member 356. Flexible track 216 is threaded through aproximal opening in rigid guide 218 and is passed over inner cylindricalguide member 330 such that the slit in flexible track 216 passes overflat support 332. In this manner flexible track 216 is positionedbetween inner cylindrical guide member 330 and cylindrical member 356.Referring to FIG. 26A cylindrical member 356 includes a longitudinalopening through which a cam member 338 extends from body 326 toward theregion defined between the inner cylindrical guide member 330 and thecylindrical member 356. As described below cam member 338 acts to lockflexible track 216 against inner cylindrical guide member 330.

Cam lock portion 322 includes a handle member 334 having a handleportion 354 and bearing surface 358 and a cam portion 355. Handle member334 includes a keyed post 352 that is connected to a bottom keyreceptacle 344 through keyed opening 350. A fastener secures handle 334to bottom key receptacle 344. Body 326 includes an opening 336 throughwhich bearing 358 and cam 355 extend. Cam plate 338 includes an aperture342 having an inner surface. Cam plate 338 includes a locking surface340. In operation cam plate 342 is positioned within a slot in body 326such that opening 342 is aligned with opening 336.

Referring to FIGS. 25A, 26A in the unlocked position lock surface 340does not abut flexible track 216. Referring to FIGS. 25B and 26B bearingmember 358 cooperates with the wall of opening 336 to centrally locatehandle 334 within opening 336. Cam member 355 is positioned withinopening 342 of cam plate 338 such that when handle 334 is rotatedlocking surface 340 is moved toward and away from rigid guide 218 tooperatively y lock and unlock flexible track 216 relative to lock 310and thereby to base 214.

Referring to FIGS. 29 and 30 Y-connector 233 is a hemostasis valve 402that includes a valve body with a first leg having a proximal port, adistal port and a lumen extending between the proximal port and thedistal port. At least one valve is located in the lumen adjacent theproximal port to permit an interventional device to be passedtherethrough. The valve body includes a second leg extending at an anglerelative to the first leg and in fluid communication with the first leg.A rotating male luer lock connector is rotatably connected to the valvebody proximate the distal port to secure proximal end of guide catheter228 thereto.

In one embodiment hemostasis valve 402 includes a bleedback valve usedto reduce the blood that may be lost during an interventional procedure.The bleedback valve acts to allow an elongated device such as a guidewire to extend therethrough but minimizes blood loss through the valve.In one embodiment hemostasis valve 402 includes a Tuohy-Borst adapterthat allows for the adjustment of the size of the opening in proximalend. Rotation of an engagement member about the valve's longitudinalaxis acts to increase or decrease the diameter of the opening.

In one embodiment the bleedback valve is opened from a closed positionto a fully opened position with a single motion or translation of anengagement member. In one example an engagement member is push or pulledalong the longitudinal axis of the elongated medical device to fullyopen or fully close the valve. Some hemostasis valve devices includeboth type of controls, a rotational engagement member that opens andcloses the tuohy borst valve by rotation of the engagement member aboutthe longitudinal axis of the engagement member and a push pull controlin which the engagement member is moved along the longitudinal axis toopen and close the bleedback valve. Other type of control mechanisms arealso known such as using a lever or ratchet to open and close the valve.

Referring to FIG. 29 and FIG. 30 hemostasis valve 402 includes anengagement member 416 that provides operation of the Tuohy-Borst valveby rotation of engagement member 416 and a push pull adjustment of thebleedback valve between a fully open and closed position by moving theengagement member 416 along the longitudinal axis of the hemostasisvalve.

Control of the Tuohy-Borst and bleed back valves is accomplishedrobotically from a remote control station 14 by a first drive member 406operatively connected to a first driven member 404 to rotate engagementmember about the longitudinal axis. In one embodiment first drive memberis a drive gear and the driven member 404 is a beveled gear secured toengagement member 416 and operatively connected to a drive gear. Asecond drive member 412 is operatively connected to the engagementmember to translate the engagement member 416 along the longitudinalaxis of the hemostasis valve. In one embodiment, second drive member isa lever that is robotically controlled via a motor that is controlled bythe remote control station 14. Lever 412 operatively engages a collarslot 414 in the outer periphery of engagement member 16 such thatmovement of the lever 412 results in the translation of the engagementmember 416 which as discussed above opens the bleedback valve betweenthe closed and open positions.

In one embodiment a user may operate the first drive member 412 and thesecond drive member 412 to open and close the bleedback and Tuohy-Borstvalves by providing instructions through a user input to rotate and/ortranslate the engagement member 416 about and/or along the longitudinalaxis. In one embodiment, first drive member 412 and the second drivemember 412 are automatically operated by a remote robotic controlstation 14 in response to a sensor that senses the blood flow and/orfictional forces required to move an elongated medical device eitherthrough the hemostasis valve and or a patients' vasculature. When thesystem detects that the force required to robotically rotate and ortranslate the elongated medical device the system reaches somepredetermined value the processor would provide instructions toincrementally open and or close the opening in one or both of thevalves. Monitoring of a patient's blood pressure and or whether blood isbeing lost through the valve would be used as factors in an algorithm todetermine the appropriate adjustment to the opening in the valves.

Referring to FIG. 27, robotic catheter system 210 operates proximate apatient bedside system 12 adjacent a patient bed 22. A remote workstation 14 includes a controller 16, a user interface 18 and a display20. An imaging system 24 may be any medical imaging system that may beused in conjunction with a catheter based medical procedure (e.g.,non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). In oneembodiment, imaging system 24 is a digital x-ray imaging device that isin communication with workstation 14. Imaging system 24 is configured totake x-ray images of the appropriate area of patient during a particularprocedure. For example, imaging system 24 may be configured to take oneor more x-ray images of the heart to diagnose a heart condition. Imagingsystem 24 may also be configured to take one or more x-ray images duringa catheter based medical procedure (e.g., real-time images) to assistthe user of workstation 14 to properly position a guide wire, guidecatheter, and a working catheter such as a stent during a procedure. Theimage or images may be displayed on display 20 to allow the user toaccurately position a distal tip of a guide wire or working catheterinto proper position in a patient's vasculature.

Referring to FIG. 28 flexible track 216 extends along the longitudinalaxis 248 toward the patient. However during a procedure the patient maymove resulting in the sheath clip pulling away or toward the patient. Inone embodiment flexible track 216 assumes an arc shape between thedistal end of cassette 222 and the patient. Guide catheter 228positioned within the cavity defined by flexible track 216 assumes thesame arc shape as flexible track 216. If a patient moves during aprocedure the away from cassette 222 the arc 390 will flatten.Similarly, if the patient moves during the procedure toward the cassette222 the arc 390 will be more pronounced. In both circumstances flexibletrack 216 prevents guide catheter 228 from buckling during a PCIprocedure.

Referring to FIG. 30 in one embodiment a sheath clip 420 is positivelyreceived within a distal end of cassette 222. The distal end of flexibletrack 216 is secured to a sheath clip 410 adjacent radially extendinghandle portion 428, sheath clip 420 includes a groove 430 having anopening 432. The distal end of flexible track 216 is located within thebottom of groove 430. In the install position shown in FIG. 31 thelongitudinal axis of sheath clip 420 is co-axial with longitudinal axis248 of robotic mechanism 212. Top position the sheath clip 420 andflexible track 216 in an operation position a user pulls handle portion428 and extends sheath clip 420 and attached flexible track 216 in adirection away from the robotic mechanism 212 and toward a patient. Inone embodiment there is no need to rotate guide sheath 420 relative tocassette 222. A user simply pulls sheath clip 420 distally in adirection away from robotic mechanism 212.

Referring to FIG. 32 and FIG. 33, sheath clip 420 includes an introducersheath connector 424 that releasably engages an introducer sheath 422.Introducer sheath connector includes at least a portion that rotatablycoupled to sheath clip 420 proximate handle portion 428. Introducersheath connector 424 includes an arm 436 that releasably engages anouter surface of introducer 422 to operatively couple the introducersheath to sheath clip 420. Arm 436 in the engaged position illustratedin FIG. 33 prevents introducer sheath 422 from moving from sheath clip420 along the longitudinal axis toward or away from the patient. A tubeextending from introducer sheath 422 is captured between sheath clip 420and arm 436.

While the foregoing written description of the invention enables one ofordinary skill to make and use what is considered presently to be thebest mode thereof, those of ordinary skill will understand andappreciate the existence of variations, combinations, and equivalents ofthe specific embodiment, method, and examples herein. The inventionshould therefore not be limited by the above described embodiment,method, and examples, but by all embodiments and methods within thescope and spirit of the invention as claimed.

What is claimed is:
 1. A robotic catheter system comprising; a base; arobotic mechanism having a longitudinal axis and being movable relativeto the base along the longitudinal axis; a flexible track releasablysecured to the base and including an outer surface having a longitudinalopening slit extending therethrough to an inner channel; a rigid guidehaving a non-linear portion fixed relative to the robotic mechanism, aportion of the flexible track moves along a non-linear path portion ofthe rigid guide when the robotic mechanism moves relative to the base.2. The robotic catheter system of claim 1 further including an elongatedmedical device operatively connected to the robotic mechanism, theelongated medical device being positioned within an inner channel of theflexible track.
 3. The robotic catheter system of claim 2, wherein theelongated medical device is a guide catheter having a linearlongitudinal axis, a portion of the flexible track moving from aposition not co-axial with the longitudinal axis of the guide catheterto a position co-axial with the longitudinal axis as the roboticmechanism moves relative to the base.
 4. The robotic catheter system ofclaim 3, wherein the guide catheter and a portion of the flexible trackare co-axial distal the robotic mechanism.
 5. The robotic cathetersystem of claim 4, wherein the guide catheter and a portion of theflexible track are not co-axial proximate the distal end of the roboticmechanism.
 6. The robotic catheter system of claim 1, wherein a portionof the flexible track is moved offset from the longitudinal axis of theelongated medical device as the robotic mechanism moves relative to thebase along the longitudinal axis.
 7. The robotic catheter system ofclaim 6, wherein the robotic mechanism includes at least one drivemechanism to drive a guide wire along the longitudinal axis.
 8. Therobotic catheter system of claim 2, wherein the elongated medical deviceis a guide wire and the robotic mechanism includes a first drive toimpart linear motion to the guide wire along the longitudinal axis and asecond drive to impart rotation motion to the guide wire about thelongitudinal axis.
 9. The robotic catheter system of claim 1, whereinthe rigid guide is fixed relative to the robotic mechanism.
 10. Therobotic catheter system of claim 9, wherein the robotic mechanismincludes a base drive portion and a separate cassette operativelysecured to the base drive portion, the rigid guide being affixed to thecassette.
 11. The robotic catheter system of claim 10, wherein theflexible track is co-axial with the guide catheter distal the cassetteand is non-coaxial with the longitudinal axis of the guide catheteralong the cassette.
 12. The robotic catheter system of claim 1, furtherincluding a clamp releasably securing a portion of the flexible track tothe base.
 13. The robotic catheter system of claim 12, wherein the clampincludes an outer cylindrical member extending into a channel of therigid guide through an opening.
 14. The robotic catheter system of claim13, wherein the outer cylindrical member includes an inner cylindricalmember operatively connected to an inner wall of the outer cylindricalmember with a connection member.
 15. The robotic system of claim 14,wherein a portion of the flexible track is positioned between inner wallof the outer cylindrical member and the inner cylindrical member and theconnection member extends through the slit of the flexible track. 16.The robotic system of claim 15, wherein the cylindrical clamp includesan engagement member that releasably presses a portion of the flexibletrack against the inner cylindrical member.
 17. The robotic system ofclaim 1, wherein the flexible track includes an opening in the outersurface of the flexible track extending from the slit proximate thedistal end of the flexible track.
 18. The robotic system of claim 17,wherein the opening extends 45 degrees or more about the flexible track.19. The robotic system of claim 18, wherein the opening tapers to theslit a predetermined distance from the distal end of the flexible tacktoward the proximal end of the flexible track, the distance beingsufficient to place a guide catheter into the opening while the guidecatheter is in a straight line.
 20. The robotic system of claim 1,further including a sheath clip operatively connected to the distal endof the flexible track, the sheath clip including an opening extendingfrom outer surface permitting the guide catheter to be inserted into thesheath clip while the guide catheter is in a straight line.
 21. Therobotic system of claim 20, wherein the sheath clip includes a connectorproximate the distal end of the sheath clip coupling an introducersheath thereto.
 22. The robotic system of claim 1, wherein the roboticmechanism includes a hemostasis valve drive, including a firstrobotically controlled drive member to open and close a first valve inthe hemostasis valve.
 23. The robotic system of claim 22, wherein thefirst valve is one of a Tough-borst valve and a bleedback valve.
 24. Therobotic system of claim 23, wherein the first drive member impartsrotation movement to an engagement member on the hemostasis valve. 25.The robotic system of claim 23, wherein the first drive member impartslinear movement to an engagement member on the hemostasis valve.
 26. Therobotic system of claim 1, wherein the proximal end and the distal endof the flexible track remain in a fixed location as the roboticmechanism is moved along the longitudinal axis.
 27. A method ofsupporting an elongated medical device comprising; translating a roboticmechanism along a longitudinal axis relative to a base, the roboticmechanism including a rigid guide having a distal portion along thelongitudinal axis and an offset portion offset from the longitudinalaxis; providing a flexible track having a slit extending into aninterior region; placing the flexible track within the rigid guide;operatively fixing a portion of the flexible track to the base moving aportion of the flexible track between the offset portion and the distalportion as the robotic mechanism extends and retracts along thelongitudinal axis.
 28. The method of claim 27 further comprising;providing an elongated medical device from the robotic mechanism alongthe longitudinal axis; and placing the flexible track about theelongated medical device proximate the juncture between the offsetportion and the distal portion of the rigid guide as the roboticmechanism extends along the longitudinal axis.
 29. The method of claim28 further comprising; removing the flexible track about the guidecatheter proximate the juncture between the offset portion and thedistal portion of the rigid guide as the robotic mechanism retractsalong the longitudinal axis.
 30. The method of claim 29 wherein theguide catheter is supported within the region of the flexible track in adirection distal to the robotic mechanism and the flexible trackincludes a portion that is offset from the longitudinal axis that doesnot support the guide catheter.
 31. The method of claim 30 wherein theflexible track is an elongated tubular member having an interior regionaccessible through the slit; and wherein placing the flexible trackabout the guide catheter includes locating the guide catheter within theinterior region of the flexible track.
 32. The method of claim 31,wherein the rigid guide includes an arcuate portion between the distalend and proximal end of the rigid guide.
 33. The method of claim 27wherein the robotic mechanism includes a cassette and a robotic drivebase, wherein the rigid track is part of the cassette.
 34. The method ofclaim 33 wherein the proximal end and the distal end of the flexibletrack remain in a fixed location as the robotic mechanism is moved alongthe longitudinal axis.
 35. An apparatus comprising: a base; a roboticmechanism movable along a longitudinal axis relative to a base by alinear drive, the robotic mechanism including a rigid guide having adistal portion along the longitudinal axis and an offset portion offsetfrom the longitudinal axis; a flexible track having an interior region,the flexible track including a portion being operatively fixed to thebase, the flexible track including a portion within the rigid guide anelongated medical device extending from the robotic mechanism andextending along the longitudinal axis; wherein a portion of the flexibletrack moves between the offset portion and the distal portion of therigid guide as the robotic mechanism extends and retracts along thelongitudinal axis and extends about the elongated medical deviceproximate the juncture between the offset portion and the distal portionof the rigid guide as the robotic mechanism extends along thelongitudinal axis.
 36. The method of claim 33 wherein the proximal endand the distal end of the flexible track remain in a fixed location asthe robotic mechanism is moved along the longitudinal axis.